Sandoz Announces Phase I Data For Its Pegfilgrastim Biosimilar - Big Molecule Watch

On December 8, 2017, Sandoz, a division of Novartis, announced data purportedly showing that its pegfilgrastim biosimilar candidate matches the reference biologic, Neulasta® in terms of pharmacokinetics, pharmacodynamics, safety and immunogenicity profiles.  The data were presented at the 2017 San Antonio Breast Cancer Symposium that was held December 5-9.

As we reported here, Sandoz’s Marketing Authorization Application for its pegfilgrastim biosimilar candidate has been accepted by the European Medicines Agency for regulatory review.  As we reported here, in July 2017 Sandoz reported that it was on track to resubmit an aBLA for its pegfilgrastim biosimilar candidate to the FDA in 2019 after having a received a complete response letter in July 2016 rejecting its previously filed aBLA.

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